Jr./Sr. Associate; Systems and Processes

Jr./Sr. Associate; Systems and Processes

Location: Beerse, Belgium (2-3 times On-Site, Remote negotiable)

Duration: until 07/06/2022 (high chances of extension)

English a must, Dutch/French preference

 2-4 Years Work Experience

Principle responsibilities

1) Performs and manages data entry activities to support department systems. Performs System administrator role for metadata maintenance.

2) Provides business level technical support and training for systems as well as data

migration and integrity initiatives as systems are updated or changed

3) Ensures department data are properly organized and maintained by the development

of process flow, job aids training and ensuring data entry follow appropriate guidelines

4) Drive operational efficiencies and effectiveness for Global CMC RA that optimizes the department's capabilities and enhances overall quality, efficiency, and productivity by ensuring systems are fit for purpose and utilized effectively

5) May participate in selected initiatives within CMC RA / GRA

6) Drives a culture of continuous improvement to ensure compliance with Johnson & Johnson standards, regulatory requirements, and expectations.

7) Communicates critical issues to Management

8) May represent CMC RA on Cross-Functional Teams

Sphere of Authority

1) Coordinates and Integrates with other CMC RA technology groups/initiatives to ensure

the needs are addressed and issues escalated as necessary

2) Works to make efficient business processes and drive continuous improvement of working practices to maximize the efficiency of the CMC RA team. Escalates critical issues to CMC RA management

3) Develop and Provide training and mentoring for the use of department IT systems

4) Effectively and tactfully communicates within CMC RA and GRA; maintain good rapport

and credibility

Position Requirements

1) Strong attention to detail with high-level verbal and written communication skills

2) Ability to effectively use computers and maintain information in a computerized data

system. Comfortable with information technology (e.g., Microsoft Excel)

3) Demonstrates model behavior that understands what the priorities are and

encourages others to drive for results

Preferred Experience

1) BS in biological, pharmaceutical, chemical, or engineering sciences or equivalent work experience (3 years)

2) Solid understanding of biology, chemistry, and/or engineering relevant to the pharmaceutical industry

3) Experience with regulatory submissions, processes, and systems

4) Good knowledge of global HA laws, regulations, guidance, and regulation submission routes available.